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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK137092 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connect4Health Engage | Experimental | Receive Connect4Health Engage |
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| Connect4Health Discover | Active Comparator | Receive Connect4Health Discover |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connect4Health Engage | Behavioral | Intervention focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion achieving ≥ 3% weight loss | Proportion of patients achieving ≥3% weight loss | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight stability at 78 weeks | Proportion of individuals who do not exceed 3% weight gain from baseline. | 78 weeks |
| Weight change at 52 weeks (continuous) | Weight change from baseline to week 52 in kgs (continuous) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
De-identified individual data will be shared with other researchers. Researchers will need to complete a Data Use Agreement.
Data will be made available within six months of completing data collection, or at the time of the first associated publication, whichever comes first.
The data and documentation will only be made available to users under a Data Use Agreement (DUA) that ensures commitments to using the data only for research purposes; to protecting identification of any individual subject; to securing the data using appropriate computer technology; and to destroying or returning the data to us after analyses are completed. To protect the privacy and confidentiality of participants and to ensure appropriate use of these data, the deidentified data will be shared in a restricted repository to be made available to qualified researchers who submit an application and execute a DUA with the appropriate participant protections. Consistent with our institution's IRB requirements, data will be available for up to five years following the study's completion.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Statistician/analyst
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| Connect4Health Discover | Behavioral | Educational control - information about healthy eating and physical activity |
|
| 52 weeks |
| Weight change at 78 weeks (continuous) | Weight change from baseline to week 78 in kgs (continuous) | 78 week |
| Weight stability at 52 weeks | Proportion of individuals who do not exceed 3% weight gain from baseline at 52 weeks. | 52 weeks |
| Minutes of moderate-to-vigorous physical activity per week at 52 weeks | Minutes of moderate-to-vigorous physical activity per week as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week) | 52 week |
| Minutes of moderate-to-vigorous physical activity per week at 78 weeks | Description: Minutes of moderate-to-vigorous physical activity per week as measured using the International Physical Activity Questionnaire (IPAQ) (continuous measure MET minutes per week) | 78 weeks |
| Servings per day of fruits and vegetables (52 weeks) | Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener. | 52 weeks |
| Servings per day of fruits and vegetables (78 weeks) | Number of servings per day of fruits and vegetables measured by Eating at America's Table Study (EATS) fruit and vegetable screener. | 78 weeks |
| Percentage of energy from fat (52 weeks) | Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure | 52 weeks |
| Percentage of energy from fat (78 weeks) | Percent of energy from fat measured using NCI Percentage Energy from Fat Screener measure | 78 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |